Dr. Kazunari Asanuma, GHTF Chair This document was produced by the Global Harmonization Task Force, a voluntary international

group of representatives from medical device regulatory authorities and trade associations from

Europe, the United States of America (USA), Canada, Japan and Australia.

The document is intended to provide non-binding guidance to regulatory authorities for use in the

regulation of medical devices, and has been subject to consultation throughout its development.

There are no restrictions on the reproduction, distribution or use of this document; however,

incorporation of this document, in part or in whole, into any other document, or its translation into languages other than English, does not convey or represent an endorsement of any kind by the Global